Certification to the ISO 9001:2008 and ISO 13485:2003 (design and manufacture of medical devices) quality management standards helps drive the success of the BCIT applied research group, PART, enabling them to meet industry clients’ needs, and enriching the learning experience of students at BCIT.
ISO 13485:2003 specifies requirements for a quality management system where an organization (BCIT) needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Quality management is focused not only on product and service quality, but also the means to achieve it.
A product or service with an ISO label creates assurance, implies reliability and is regarded more highly for having gone through such a thorough and rigorous process. PART’s certification means that their industry clients have access to the skills and systems to move their research out of the lab and into the market place.
For BCIT students, the opportunity to work under the ISO quality management systems “… adds enormous benefit to BCIT through training of students who work with PART members for both Capstone and summer projects.” says Dr. Jim Booth of BCIT’s Physics Department.
Beyond the classroom, ISO Quality Management experience holds significant weight with employers and can lead to full-time career opportunities. “This year we have a number of graduates who found employments in medical device companies immediately after their graduation. Working with your group during their Capstone projects is one of the key factors in landing their jobs in the biomedical device industry”, says Dr. Anthony Chan, Program Head, BCIT Biomedical Engineering.
PART is part of MAKE+, an applied research group provides innovative, cost effective and continually improving product and process development services and education.
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